Gabriel Bistika
Worcester,MA
Summary
Dedicated and hard working team member well-versed in manufacturing processes, excelling in GxP compliance regarding both electronic and manual batch record review. Almost five years of manufacturing process experience, executing and providing detailed communications with all relevant parties regarding process results, expectations, and priorities. Lab leadership experience training and guiding new associates on processes and batch record review. Proven ability to enhance process integrity through effective inter-team communication and strong time management skills.
Overview
5
5
years of professional experience
Work History
Manufacturing Associate II
Lantheus
North Billerica, MA
12.2024 - Current
- Perform 100% visual inspection of DEFINITY@ vials under controlled lighting conditions to detect defects such as particulates, container closure issues, or cosmetic flaws.
- Perform routine operations following Standard Operating Procedures.
- Manage inventory using SAP, ensuring accurate tracking and availability of materials.
- Collaborate with Quality Assurance, Engineering, and other teams to support batch release, investigations, and continuous improvements.
- Conduct visual inspections of drug products and containers to ensure quality and patient safety.
- Perform in-process and final inspections of components, packaging, and finished vials to verify compliance with specifications.
- Execute and review Manufacturing Batch Records in compliance with Good Documentation Practices.
- Work in a cleanroom environment, following gowning procedures and contamination control protocols.
- Contribute to daily shift meetings and provide feedback for improving inspection processes and efficiency.
Manufacturing Associate II
Moderna Inc.
Norwood, MA
04.2023 - 12.2024
- Strict adherence to GMP/GxP, Standard Operating Procedures, and manufacturing documentation to ensure the highest quality standards.
- Executed and reviewed both Electronic Batch records and Manufacturing Batch Records in compliance with Good Documentation Practices.
- Routinely execute manufacturing operations following established SOPs: weighing, in-process testing, filtration, CIP, aliquoting, and batch kitting.
- Supported quality control by preparing and submitting samples via the LIMS system LabVantage for analytical testing, reviewing results, and collaborating with QC/QA to resolve discrepancies.
- Used the LIMS system LabVantage to enter sample information before every sample delivery.
- Assisted with deviation reporting and CAPA implementation to strengthen compliance and product integrity.
- Proficient in Syncade software for executing electronic batch records and ensuring accurate, compliant documentation.
- Proficient in SAP for overseeing inventory, charging materials to process orders, creating reservations, and coordinating with logistics.
- Used electronic workflows such as LIMS LabVantage, Veeva Quality Docs, ServiceNow, LMS, OSIsoft PI Vision, and InfoBatch for documentation, compliance, and business processes.
- Partnered with QC, QA, MS&T, facilities, logistics, and manufacturing management during troubleshooting, audits, and inspections.
Manufacturing Associate
Repligen Corporation
Waltham, MA
06.2022 - 04.2023
- Worked with a team of skilled operators in downstream purification processes.
- Exceptional multi-tasker, keeping track of multiple operations and personnel to ensure process integrity is maintained.
- Assisted with reviewing Manufacturing Batch Records in compliance with Good Documentation Practices.
- Strict adherence to growing procedures and maintaining a clean general operating area.
- Adhered to Repligen safety procedures and guidelines while practicing safe work habits.
- Maintained waste handling procedures in accordance with environmental regulations.
Manufacturing Associate I
Moderna Inc.
Norwood, MA
11.2021 - 05.2022
- Strict adherence to GMP/GxP, Standard Operating Procedures, and manufacturing documentation to ensure the highest quality standards.
- Executed and reviewed Manufacturing Batch Records in compliance with Good Documentation Practices.
- Routinely executed manufacturing operations following established SOPs: weighing, in-process testing, filtration, CIP, aliquoting, and batch kitting.
- Supported quality control by preparing and submitting samples via LIMS system LabVantage for analytical testing, reviewing results, and collaborating with QC/QA to resolve discrepancies.
- Used LIMS system LabVantage to enter sample information before every sample delivery.
- Assisted with deviation reporting and CAPA implementation to strengthen compliance and product integrity.
- Proficient in Syncade software for executing electronic batch records and ensuring accurate, compliant documentation.
- Proficient in SAP for overseeing inventory, charging materials to process orders, creating reservations, and coordinating with logistics.
- Used electronic workflows such as LIMS LabVantage, Veeva Quality Docs, ServiceNow, LMS, OSIsoft PI Vision, and InfoBatch for documentation, compliance, and business processes.
- Partnered with QC, QA, MS&T, facilities, logistics, and manufacturing management during troubleshooting, audits, and inspections.
Education
High School Diploma -
Doherty Memorial High School
Worcester, MA05-2021
Skills
- Manufacturing Processes
- Electronic Batch Review
- Manual Batch Review
- GxP/ALCOA Compliance
- MES Systems
- LIMS LabVantage
- Veeva Quality Docs
- ServiceNow
- Mira Receiving Inventory
- Microsoft Office
- Excellent Time Management
- Strong inter-team communication skills
- Confidence Training team members
- Technical Communication
- Task Communication and Delegation
Timeline
Manufacturing Associate II
Lantheus
12.2024 - Current
Manufacturing Associate II
Moderna Inc.
04.2023 - 12.2024
Manufacturing Associate
Repligen Corporation
06.2022 - 04.2023
Manufacturing Associate I
Moderna Inc.
11.2021 - 05.2022
High School Diploma -
Doherty Memorial High School